Over-The-Counter Hearing Aids: Are They Safe and Effective?

OBJECTIVE: In 2022, the Food and Drug Administration established a new regulatory category for over-the-counter (OTC) hearing aids for mild to moderate hearing loss. Herein, we aim to better compare the safety and efficacy of these devices to that of prescription hearing aids. STUDY DESIGN: Comparative-effectiveness model. SETTING: Academic Audiology Center. METHODS: The safety and efficacy of prescription and OTC hearing aids was compared using the AudioScan Verifit 2 Testbox software. Three types of hearing loss (downsloping, sharp downsloping, and reverse sloping) were analyzed. Efficacy was tested at 3 volume inputs and was measured by calculating the average difference in test points (produced by the devices) and target points (estimated by the software). Safety was assessed by calculating the average difference in test points and the maximally safe hearing level (produced by the software). RESULTS: Prescription hearing aids were found to have a better safety profile by being further from the safety threshold compared to OTC devices at the 8000 Hz frequency for the 2 types of downsloping hearing loss patterns studied (48 vs 30.5 dB, P = .04; 51 vs 32.5 dB, P = .03). Prescription hearing aids also carried a statistically significant advantage at 3 test points. OTC hearing aids generally had a greater difference between test and target points. CONCLUSION: OTC and prescription hearing aids are comparably safe, though OTC hearing aids are slightly less efficacious. Further evaluation of the OTC hearing aid efficacy is warranted to ensure it provides the gain of benefit needed for different types of hearing loss.

Over-The-Counter Hearing Aids: Trends in Information-Seeking Behavior.

Recent Food and Drug Administration approval of over-the-counter (OTC) hearing aids has changed the policy landscape surrounding hearing-assistive technology. Our objective was to characterize trends in information-seeking behavior in the era of OTC hearing aids. Using Google Trends, we extracted the relative search volume (RSV) for hearing health-related topics. The mean RSV in the 2 weeks preceding and following enactment of the FDA's OTC hearing aid ruling were compared using a paired samples t-test. RSV for hearing-related queries increased by 212.5% on the date of FDA approval. There was a 25.6% (p = .02) increase in mean RSV for "hearing aids" before and after the FDA ruling. The most popular searches focused on specific device brands and cost. States with more rural residents represented the highest proportion of queries. Understanding these trends is critical to ensure appropriate patient counseling and improve access to hearing assistive technology.

Long-term laryngological sequelae and patient-reported outcomes after COVID-19 infection.

PURPOSE: We examine prevalence, characteristics, quality of life (QOL) assessments, and long-term effects of interventions for laryngeal dysfunction after recovery from COVID-19 infection. MATERIALS AND METHODS: 653 patients presenting to Yale's COVID clinic from April 2020 to August 2021 were identified retrospectively. Patients with PCR-positive COVID-19 who underwent evaluation by fellowship-trained laryngologists were included. Patient demographics, comorbidities, intubation/tracheostomy, strobolaryngoscopy, voice metrics, and management data were collected. Patient-reported QOL indices were Dyspnea Index (DI), Cough Severity Index (CSI), Voice Handicap Index-10 (VHI-10), Eating Assessment Tool-10 (EAT-10), and Reflux Symptom Index (RSI). RESULTS: 57 patients met inclusion criteria: 37 (64.9 %) were hospitalized for COVID-19 infection and 24 (42.1 %) required intubation. Mean duration between COVID-19 diagnosis and presentation to laryngology was significantly shorter for patients who were intubated compared to non-intubated (175 ± 98 days versus 256 ± 150 days, respectively, p = 0.025). Dysphonia was diagnosed in 40 (70.2 %) patients, dysphagia in 14 (25.0 %) patients, COVID-related laryngeal hypersensitivity in 13 (22.8 %), and laryngotracheal stenosis (LTS) in 10 (17.5 %) patients. Of the 17 patients who underwent voice therapy, 11 (64.7 %) reported improvement in their symptoms and 2 (11.8 %) patients reported resolution. VHI scores decreased for patients who reported symptom improvement. 7 (70 %) patients with LTS required >1 procedural intervention before symptom improvement. Improvement across QOL indices was seen in patients with LTS. CONCLUSIONS: Laryngeal dysfunction commonly presents and is persistent for months after recovery from COVID-19 in non-hospitalized and non-intubated patients. Voice therapy and procedural interventions have the potential to address post-COVID laryngeal dysfunction.

Prophylactic Intraoperative Antibiotic Dosing in Head and Neck Surgery: Opportunities for Improvement and Future Study.

OBJECTIVES: To investigate rates of Surgical Care Improvement Project (SCIP) guideline adherence with regard to intraoperative antibiotic prophylaxis in head and neck surgery with free tissue transfer. STUDY DESIGN: Retrospective case series. SETTING: A single academic center. METHODS: All patients who underwent mucosa-violating head and neck oncologic surgery with free tissue transfer between March 2017 and June 2019 were reviewed. Intraoperative antibiotic data included type, dosage, frequency of administration, and duration. Any deviation from SCIP recommendations was defined as nonadherence. Antibiotic type was categorized as ampicillin-sulbactam, cefazolin/metronidazole, clindamycin, and others. As a secondary exploratory analysis, postoperative infections were analyzed and stratified by adherent vs nonadherent and by antibiotic type. RESULTS: A total of 129 surgical procedures were included. The mean ± SD number of antibiotic doses during surgery was 3.16 ± 1.2. The mean number of missed doses was 1.86 ± 1.65. Adherence rate with first dosing recommendation was 100%, as compared with 41.7% for dose 2, 23.1% for dose 3, 13.7% for dose 4, 5.26% for dose 5, 2.56% for dose 6, and 0% for dose 7 (P < .001). Ampicillin-sulbactam (6.4%) had a significantly lower rate of average redosing adherence when compared with cefazolin/metronidazole (73.2%) and clindamycin (63.3%; P < .001). CONCLUSION: Significant opportunities exist in SCIP guideline adherence rates for intraoperative antibiotic prophylaxis. Cefazolin/metronidazole had a significantly higher rate of appropriate redosing when compared with ampicillin-sulbactam, which should be considered when choosing a prophylactic antibiotic regimen and performing antibiotic-based outcomes studies. More attention should be given to intraoperative antibiotic prophylaxis in head and neck surgery with free tissue transfer, as this presents an opportunity for quality improvement and future study heretofore not explored.

Characterizing Medicare Reimbursements and Clinical Activity Among Female Otolaryngologists.

OBJECTIVE: To evaluate geographic and temporal trends in Medicare fee-for-service (FFS) billing and reimbursements across female otolaryngologists (ORL). METHODS: We performed a cross-sectional, retrospective analysis of the 2017 Medicare Physician and Other Suppliers Aggregate File. We analyzed differences in the number of services, patients, reimbursements, unique Current Procedural Terminology (CPT) codes used, and services billed per patient among female ORLs. RESULTS: Female ORLs accounted for 15.2% of the 8453 Medicare-reimbursed ORLs. Female ORLs who graduated between 2000 and 2010 were reimbursed a median of $58 031.9 (IQR: $32 286.5-$91 512.2) and performed a median of 702 (IQR: 359.5-1221.5) services, significantly less than those who graduated between 1990 and 1999 (median: $67 508.9; IQR: 37 018.0-110 471.5; P < .001; median: 1055.5; IQR: 497.3-1944; P < .001). Female ORLs who graduated between 2000 and 2010 saw a median of 232 patients (IQR: 130.5-368), significantly less than those who graduated between 1990 and 1999 (median: 308; IQR: 168.3-496; P < .001) patients, significantly more than those. Female ORLs in urban settings performed a median of 795 (IQR: 364-1494.3) services and billed for a median of 42 (IQR: 28-58) unique codes, significantly fewer than their counterparts in rural settings (median: 1096; IQR: 600-2192.5; P = .002; median: 54; IQR: 31.5-64.5; P = .001). CONCLUSIONS: Medicare reimbursements and billing patterns across female ORLs varied by graduation decade and geography. Female ORLs further along in their careers may be reimbursed more with greater clinical volume and productivity. Those practicing in urban settings may have practices with decreased procedural diversity and lower clinical volume compared to their counterparts in rural areas.

Sexual and reproductive health information and referrals for resettled refugee women: A survey of resettlement agencies in the United States.

BACKGROUND: Refugee resettlement offices are the first point of contact for newly arrived refugees and play a significant role in helping refugees acclimate and settle into life in the United States. Available literature suggests that refugee women are vulnerable to poor sexual and reproductive health (SRH) outcomes, including sexually transmitted infections and HIV infections as well as adverse pregnancy outcomes, but little is known about the role that refugee resettlement offices play in supporting refugee women's SRH. This study examines the capacity and interest of resettlement offices in providing SRH information and referrals to newly arrived refugees. METHODS AND FINDINGS: The research team conducted an online survey of staff members at refugee resettlement offices throughout the US in 2018 to determine (1) available SRH resources and workshops; (2) referrals to and assistance with making appointments for SRH and primary care appointments; (3) barriers to addressing SRH needs of clients; and (4) interest in building the capacity of office staff to address SRH issues. The survey was created for this study and had not been previously used or validated. Survey data underwent descriptive analysis. A total of 236 resettlement offices were contacted, with responses from 100 offices, for a total response rate of 42%. Fifteen percent (N = 15) of refugee resettlement agencies (RRAs) who responded to the survey provide materials about SRH to clients, and 49% (N = 49) incorporate sexual health into the classes they provide to newly arrived refugee clients. Moreover, 12% (N = 12) of responding RRAs screen clients for pregnancy intention, and 20% (N = 20) directly refer to contraceptive care and services. This study is limited by the response rate of the survey; no conclusions can be drawn about those offices that did not respond. In addition, the survey instrument was not validated against any other sources of information about the practices of refugee resettlement offices. CONCLUSIONS: In this study, we observed that many resettlement offices do not routinely provide information or referrals for SRH needs. Responding offices cite lack of time and competing priorities as major barriers to providing SRH education and referrals to clients.

State Medicaid expansion status, insurance coverage and stage at diagnosis in head and neck cancer patients.

OBJECTIVES: Only one in three head and neck cancer (HNC) patients present with early-stage disease. We aimed to quantify associations between state Medicaid expansions and changes in insurance coverage rates and stage at diagnosis of HNC. METHODS: Using a quasi-experimental difference-in-differences (DID) approach and data from 26,330 cases included in the Surveillance, Epidemiology, and End Results program (2011-2015), we retrospectively examined changes in insurance coverage and stage at diagnosis of adult HNC in states that expanded Medicaid (EXP) versus those that did not (NEXP). RESULTS: There was a significant increase in Medicaid coverage in EXP (+1.6 percentage point (PP) versus) vs. NEXP (-1.8 PP) states (3.36 PP, 95% CI = 1.32, 5.41; p = 0.001), and this increase was mostly among residents of low income and education counties. We also observed a reduction in uninsured rates among HNC patients in low income counties (-4.17 PP, 95% CI = -6.84, -1.51; p = 0.002). Overall, early stage diagnosis rates were 28.3% (EXP) vs. 26.7% (NEXP), with significant increases in early stage diagnosis post-Medicaid expansion among young adults, 18-34 years (17.2 PP, 95% CI - 1.34 to 33.1, p = 0.034), females (7.54 PP, 95% CI = 2.00 to 13.10, p = 0.008), unmarried patients (3.83 PP, 95% CI = 0.30-7.35, p = 0.033), and patients with lip cancer (13.5 PP, 95% CI = 2.67-24.3, p = 0.015). CONCLUSIONS: Medicaid expansion is associated with improved insurance coverage rates for HNC patients, particularly those with low income, and increases in early stage diagnoses for young adults and women.

How the World's Children Hear: A Narrative Review of School Hearing Screening Programs Globally.

OBJECTIVE: School hearing screening may mitigate the effects of childhood hearing loss through early identification and intervention. This study provides an overview of existing school hearing screening programs around the world, identifies gaps in the literature, and develops priorities for future research. DATA SOURCES: A structured search of the PubMed, Embase, and Cochrane Library databases. REVIEW METHODS: A total of 65 articles were included according to predefined inclusion criteria. Parameters of interest included age groups screened, audiometric protocols, referral criteria, use of adjunct screening tests, rescreening procedures, hearing loss prevalence, screening test sensitivity and specificity, and loss to follow-up. CONCLUSIONS: School hearing screening is mandated in few regions worldwide, and there is little accountability regarding whether testing is performed. Screening protocols differ in terms of screening tests included and thresholds used. The most common protocols included a mix of pure tone screening (0.5, 1, 2, and 4 kHz), otoscopy, and tympanometry. Estimates of region-specific disease prevalence were methodologically inaccurate, and rescreening was poorly addressed. Loss to follow-up was also a ubiquitous concern. IMPLICATIONS FOR PRACTICE: There is an urgent need for standardized school hearing screening protocol guidelines globally, which will facilitate more accurate studies of hearing loss prevalence and determination of screening test sensitivity and specificity. In turn, these steps will increase the robustness with which we can study the effects of screening and treatment interventions, and they will support the development of guidelines on the screening, diagnostic, and rehabilitation services needed to reduce the impact of childhood hearing loss.

Change in stage of presentation of head and neck cancer in the United States before and after the affordable care act.

OBJECTIVE/HYPOTHESIS: Early diagnosis and stage at presentation, two prognostic factors for survival among patients with head and neck cancer (HNC), are significantly impacted by a patient's health insurance status. We aimed to assess the impact of the Patient Protection and Affordable Care Act (ACA) on stage at presentation across socioeconomic and demographic subpopulations of HNC patients in the United States. STUDY DESIGN: Retrospective data analysis. METHODS: The National Cancer Database, a hospital-based cancer database (2011-2015), was queried for adults aged 18-64 years and diagnosed with a malignant primary HNC. The outcome of interest was change in early-stage diagnoses between 2011-2013 (pre-ACA) and 2014-2015 (post-ACA) using logistic regression models. RESULTS: A total of 91,137 HNC cases were identified in the pre-ACA (n = 53,726) and post-ACA (n = 37,411) years. Overall, the odds of early-stage diagnoses did not change significantly post-ACA (aOR = 0.97, 95 % CI 0.94, 1.00; p = 0.081). However, based on health insurance status, HNC patients with Medicaid were significantly more likely to present with early-stage disease post-ACA (aOR = 1.12, 95 % CI 1.03, 1.21; p = 0.007). We did not observe increased odds of early-stage presentation for other insurance types. Males were less likely to present with early-stage disease, pre- or post-ACA. CONCLUSIONS: We demonstrate a significant association between ACA implementation and increased early-stage presentation among Medicaid-enrolled HNC patients. This suggests that coverage expansions through the ACA may be associated with increased access to care and may yield greater benefits among low-income HNC patients.

Insurance status, stage of presentation, and survival among female patients with head and neck cancer.

OBJECTIVES: Incidence trends and outcomes of head and neck cancer (HNC) among female patients are not well understood. The objective of this study was to estimate incidence trends and quantify the association between health insurance status, stage at presentation, and survival among females with HNC. STUDY DESIGN: Retrospective cohort study. METHODS: The Surveillance, Epidemiology, and End Results database (2007-2014) was queried for females aged ≥18 years diagnosed with a malignant primary head and neck cancer (HNC) (n = 18,923). Incidence trends for stage at presentation were estimated using Joinpoint regression analysis. The association between health insurance status and stage at presentation on overall and disease-specific survival was estimated using Fine and Gray proportional hazards models. RESULTS: Incidence of stage IV HNC rose by 1.24% from 2007 to 2014 (annual percent change = 1.24, 95% CI 0.30, 2.20). Patients with Medicaid (adjusted odds ratio [aOR] = 1.59, 95% confidence interval [CI] 1.45, 1.74) and who were uninsured (aOR = 1.73, 95% CI 1.47, 2.04) were more likely to be diagnosed with advanced stage (stages III/IV) HNC. Similarly, patients with Medicaid (adjusted hazard ratio [aHR] = 1.47, 95% CI 1.38, 1.56) and who were uninsured (aHR =1.45, 95% CI 1.29, 1.63) were more likely to die from any cause compared to privately insured patients. Medicaid (aHR = 1.34, 95% CI 1.24, 1.44) and uninsured (aHR = 1.41, 95% CI 1.24, 1.60) patients also had a greater hazard of HNC-specific deaths compared to privately insured patients. CONCLUSIONS: Incidence of advanced-stage presentation for female HNC patients in the United States has increased significantly since 2007, and patients who are uninsured or enrolled in Medicaid are more likely to present with late stage disease and die earlier. LEVEL OF EVIDENCE: NA Laryngoscope, 130:385-391, 2020.

Socioeconomic and Demographic Variation in Insurance Coverage Among Patients With Head and Neck Cancer After the Affordable Care Act.

Importance: Health insurance status has a significant association with early diagnosis and stage at presentation, which are the most important predictors of survival among patients with head and neck cancer (HNC). Literature on the association of the Patient Protection and Affordable Care Act (ACA) with changes in insurance status among patients with HNC remains limited. To our knowledge, no studies have evaluated changes in insurance rates across sociodemographic subgroups of patients with HNC. Objective: To assess the association of the implementation of the ACA with insurance status across socioeconomic and demographic subpopulations of patients with HNC. Design, Setting, and Participants: A retrospective cohort study using data from the National Cancer Database (NCDB), a hospital-based cancer registry (2011-2015) for adults diagnosed with a malignant primary HNC was carried out. The analyses were conducted from November 2018 through December 2018. Main Outcomes and Measures: Changes in the percentage of patients with insurance. Results: A total of 131 779 patients with HNC were identified in the pre-ACA (77 071) and post-ACA (54 708) periods. Overall, 98 207 (74.5%) participants were men and 33 572 (25.5) were women, with 73 124 (55.5%) being aged between 50 to 64 years. There was a 2.68 percentage point decrease (PPD) (95% CI, 2.93-2.42) in the percentage of patients with HNC without insurance from the pre-ACA to the post-ACA period. Changes in the percentage of uninsured patients varied significantly by age, with the largest reduction in uninsured status among patients with HNC aged 18 to 34 years (5.12 PPD; 95% CI, 3.18-7.06) and the smallest reduction in uninsured among those aged 65 to 74 years (0.24 PPD; 95% CI, 0.03-0.45). There was a significantly greater reduction in uninsured status in low-income zip codes (3.45 PPD; 95% CI, 2.76-4.14) than in high-income zip codes (1.99 PPD; 95% CI, 1.63-2.36). Conclusions and Relevance: There was a significant association between ACA implementation and percentage decrease in uninsured patients. Young adults and those residing in low-income zip codes experienced a significantly higher rate of insurance uptake compared with older adults and residents of high-income areas. This suggests that coverage expansions enacted through the ACA are not only associated with increased access to care among the broader HNC population, but that they may also yield a greater benefit among subpopulations with historically limited insurance coverage.

The Influence of Diet on Fertility and the Implications for Public Health Nutrition in the United States.

Despite growing evidence of the impact of diet on human fertility, few studies have examined the public health implications of this association in the United States (U.S.). This narrative review summarizes current scientific evidence on associations between dietary intake and fertility, discusses challenges in the public health landscape surrounding infertility, and proposes evidence-based recommendations to address these issues. Diets high in unsaturated fats, whole grains, vegetables, and fish have been associated with improved fertility in both women and men. While current evidence on the role of dairy, alcohol, and caffeine is inconsistent, saturated fats, and sugar have been associated with poorer fertility outcomes in women and men. Furthermore, women and men with obesity [body mass index (BMI) ≥ 30 kg/m2] have a higher risk of infertility. This risk is extended to women who are underweight (BMI <20 kg/m2). Diet and BMI influence outcomes during clinical treatment for infertility. Further, women in the U.S. who belong to an underrepresented minority group, have low income, or have low educational attainment, have significantly higher rates of infertility outcomes as compared to women who are non-Hispanic white, have high income, or have high educational attainment. Given this, it may be prudent to integrate nutrition counseling into both clinical guidelines for infertility as well as national dietary guidelines for individuals of reproductive age. Further studies on diet and reproductive health may enhance our ability to improve existing fertility programs across the U.S. and to deliver tailored care to women and men within at-risk groups.